Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Hip Fracture Intervention Trial (HIPFIT): A randomized controlled trial of a targeted multifactorial intervention to improve long term disability after hip fracture

Query!

Secondary ID [1]2522120

Hip Fracture Intervention Trial

Query!

Universal Trial Number (UTN)

Query!

Trial acronym

HIPFIT

Query!

Linked study record

Query!

Health condition

Health condition(s) or problem(s) studied:

Fracture neck of femur2590

Query!

Condition category

Condition code

Injuries and Accidents29129100

Query!

Fractures

Query!

Intervention/exposure

Study type

Interventional

Query!

Description of intervention(s) / exposure

Intervention group receives one or more of the following treatments, depending on their condition, the outcome of the assessments and the recommendations from the geriatricians and the multidiciplinary team: 1. Progressive resistance training (all participants); 2 x 1 hour session per week for 12 months in small groups of maximum 4 participants supervised by exercise physiologist. High intensity progressive resistance training on pneumatic resistance machines.Volume: 3 sets of 8 repetitions on 7 machines: leg press, standing hip extension and abduction, knee extension, knee flexion, triceps, chest press, seated rowIntensity: 80% of most recent one repetition maximum (1RM) or rating less than 15 on Borg's scale of perceived exertion.

6. Depression treatment:- Resistance training 2 days a week, Frequency-3 sets of 8 reps on 7 machines Intensity-80% of most recent one repetition maximum (1 RM) or rating less than 15 on Borg's perceived exertion scale.- Pleasurable events scheduled as appropriate- Problem solving as needed - Optimise medical condition by geriatrician and reviewed monthly - Antidepressant: Cipramil if determined by geriatrician review and repeat gds scale at one month that prt and cbt were not sufficient

7. Visual impairment support/referral:- Cataract extraction referral at time of initial assessment by ophtalmologist- New prescription for read/distance glasses at time of initial assessment by ophtalmologist- Elimination of bifocals as part of new glasses prescription- New glaucoma medications - Home modifications at initial visit & followed up monthly by research staff- Referral to Blind Society services/resources- Provision of support for ADL’s unable to be done due to visual impairment as needed

9. Hip protectors (all participants):Hip protectors are shields worn over the hip bone to assist in preventing hip fracture in the event of a fall. The soft silicone shields that absorb the force of an impact caused by a fall onto the hip are held in place by specially designed underwear.When to wear: Put on in the morning when dressing and take off at night when going to bed.How to wear:1)place the shields in the inside pockets of the pants:-hollow side faces in, towards the hip-rounded side faces out, away from the hip2) put on as normal underpants so that the pants are well adjusted with the shields at hip height

10. Social support network optimisation:Individual packages varying according to the individual’s needs, for the 12 months of the study participation & reviewed at monthly visits. One or more of the following involved:- Practical care such as services to help with self care, meals, medications, cleaning & shopping- Social and emotional support through regular planned visits and phone calls- Information and advice relevant to the rehabilitation process and/or availability of appropriate programs or services- Monthly visit by research staff

11 Self-efficacy education/training:Self-efficacy as needed one or more of the following administered face to face by research staff and reviewed at monthly visits and administered by group education sessions- Use of confidence stepladder- Exploring barriers and overcoming obstacles - Breaking down skills, practice, reframing negative statements

12. Management of polypharmacy:management of polypharmacy- Medication review by geriatrician- Consultation with General Practitioner- Education of patient/caregiver- Completion of medical record card from pharmacy

The overall period duration of this intervention 12 months with yearly follow-up for 4 years (at 2, 3, 4 and 5 years post hip fracture). The intervention group is being monitored closely throughout the 12 months. For both groups, the assessments are done at 3 timepoints: baseline, 4 months and 12 months. Update description of intervention(s) / exposure:Participants are also called yearly for the next 4 years following the 12 month assessment to ascertain functional and residency status.

Query!

Intervention code [1]1760

Treatment: Other

Query!

Comparator / control treatment

Control group is assessed at baseline, 4 and 12 months and a letter sent to their general practitioner (GP) at each time point identifying any abnormalities in vision, vitamin D, depression, or cognition. No recommendations for specific treatment made.

Query!

Control group

Active

Query!

Outcomes

Primary outcome [1]3390

1. Disability: Place of residence (nursing home or community), Blinded assessment of Functional Independence Measure (FIM) and Assessment of Living Skills and Resources (ALSAR); unblinded assessment of Katz Activities of Daily Living (ADL) scale, The National Health and Nutrition Examination Survey (NHANES) Functional Status Survey for ADL, Instrumental Activities of Daily Living (IADL) dependency and assistive device utilization and availability

Age under 55DementedTerminally illUnwilling or unable to participate in study protocols

Query!

Study design

Purpose of the study

Treatment

Query!

Allocation to intervention

Randomised controlled trial

Query!

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Concealed allcation is being carried out by a personnel who has no contact with recruited subjects

Query!

Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Computerised random allocation

Query!

Masking / blinding

Open (masking not used)

Query!

Who is / are masked / blinded?

Query!

Query!

Query!

Query!

Intervention assignment

Parallel

Query!

Other design features

Query!

Phase

Query!

Type of endpoint(s)

Efficacy

Query!

Statistical methods / analysis

Query!

Recruitment

Recruitment status

Active, not recruiting

Query!

Date of first participant enrolment

Anticipated

1/02/2002

Query!

Actual

Query!

Date of last participant enrolment

Anticipated

Query!

Actual

Query!

Date of last data collection

Anticipated

Query!

Actual

Query!

Sample size

Target

284

Query!

Accrual to date

Query!

Final

Query!

Recruitment in Australia

Recruitment state(s)

Query!

Recruitment postcode(s) [1]1980

2141

Query!

Funding & Sponsors

Funding source category [1]3500

Government body

Query!

Name [1]3500

NHMRC

Query!

Address [1]3500

Level 5, 20 Allara StreetCivic ACT 2601

Query!

Country [1]3500

Australia

Query!

Primary sponsor type

Government body

Query!

Name

NHMRC

Query!

Address

Level 5, 20 Allara StreetCivic ACT 2601

Query!

Country

Australia

Query!

Secondary sponsor category [1]2750

University

Query!

Name [1]2750

The University of Sydney

Query!

Address [1]2750

75 East StreetLidcombe NSW 2141

Query!

Country [1]2750

Australia

Query!

Ethics approval

Ethics application status

Approved

Query!

Ethics committee name [1]13150

Central Sydney Area Health Services

Query!

Ethics committee address [1]13150

Query!

Ethics committee country [1]13150

Australia

Query!

Date submitted for ethics approval [1]13150

Query!

Approval date [1]13150

Query!

Ethics approval number [1]13150

Query!

Ethics committee name [2]13160

The University of Sydney

Query!

Ethics committee address [2]13160

Query!

Ethics committee country [2]13160

Australia

Query!

Date submitted for ethics approval [2]13160

Query!

Approval date [2]13160

Query!

Ethics approval number [2]13160

Query!

Summary

Brief summary

Many patients with hip fracture end up disabled or in nursing homes in the year following fracture. Current treatment protocols do not systematically address risk factors for disability. We will recruit 600 patients who have fractured their hip. Subjects will be randomized to receive usual care or the HIPFIT intervention, which includes targeted treatments for depression, muscle weakness, poor gait and balance, malnutrition, vitamin D deficiency, poor vision, environmental hazards in the home, social isolation, and low self-efficacy, as needed. The two groups will be followed for 12 months to determine differences in disability and need for residential care.

Query!

Trial website

Query!

Trial related presentations / publications

Query!

Public notes

Query!

Contacts

Principal investigator

Name
355070

Query!

Address
355070

Query!

Country
355070

Query!

Phone
355070

Query!

Fax
355070

Query!

Email
355070

Query!

Contact person for public queries

Name
93650

Professor Maria Fiatarone Singh

Query!

Address
93650

School of Exercise and Sport ScienceThe University of SydneyEast StreetLidcombe NSW 2141

Query!

Country
93650

Australia

Query!

Phone
93650

+61 2 93519755

Query!

Fax
93650

+61 2 93519204

Query!

Email
93650

maria.fiataronesingh@sydney.edu.au

Query!

Contact person for scientific queries

Name
2930

Professor Maria Fiatarone Singh

Query!

Address
2930

School of Exercise and Sport ScienceThe University of SydneyEast StreetLidcombe NSW 2141